OximetryMoxiCovNCT04587921
Feasibility and Impact of Remote Oximetry in Patients Hospitalized With Covid-19
A study testing Digital oximeter monitoring in people with Oximetry and Covid19, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The objective of MoxiCov is to monitor the oximetry of patients admitted to the Covid nursery to provide a more detailed assistance expecting to reduce the amount of hypoxia in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Digital oximeter monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Jun 2020to 22 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old
- COVID 19 positive or suspected COVID19
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Fundação Zerbini - Instituto do Coração (InCor)
São Paulo, São Paulo, 054039000
Diego Prieto, Msc, 55 11 2661-5486, diego.campos.prieto@gmail.com
Daniel Queiróz, PhD, 55 11 2661-5486, daniel.bc.queiroz@gmail.com
About this study
Official title: Feasibility and Impact of Remote Oximetry and Cardiac Frequency Monitoring in Patients Hospitalized and Isolated With Covid-19
The objective of MoxiCov is to monitor the oximetry of patients admitted to the Covid nursery to provide a more detailed assistance expecting to reduce the amount of hypoxia in these patients.
- Being tested
- Digital oximeter monitoring
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital oximeter monitoringDevice
Digital oximeter and cardiac frequency monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Patients monitored with oximeter | Experimental | The first 45 patients will be monitored but the results will not be displayed. The second half of the patients the oximeter will have their monitoring data available online in the ward. Receives: Device: Digital oximeter monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the system: Determination of the number of valid versus not valid or missed measurements
Determination of the number of valid versus not valid or missed measurements of each participant.
Measured: 6 months
Hypoxic burden
Time spent with SpO2< 93%, 90% and 85%
Measured: 6 months
Hypoxic alarm
Number of times the oximeter record 3 consecutive measurements of SpO2<90%
Measured: 6 months
Satisfaction of the nursing, medical team and patients with the implemented system
Measurement of NET PROMOTING SCORE (NPS). This score will show the satisfaction of the healthcare team with the device. This score have a minimum of 0 points and maximum of 32 points.
Measured: 6 months
Secondary outcomes (5)
Time of SpO2<90%, SpO2<85% and SpO2<80%
Measured: 6 months
Number of false alarms caused by malfunctions or bad oximeter positioning
Measured: 6 months
Total hospital stay
Measured: 6 months
Time of supplementary oxygen use
Measured: 6 months
Mortality of participants
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start22 Jun 2020
- Primary completion22 Jan 2021 (estimated)
- Study completion22 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OximetryStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geraldo Lorenzi Filho, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587921
- Sponsor's protocol ID
- 5058/20/087
- Acronym
- MoxiCov
- Status last verified
- Oct 2020
- First submitted
- 18 Aug 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Impact of Remote Oximetry and Cardiac Frequency Monitoring in Patients Hospitalized and Isolated With Covid-19
- ClinicalTrials.gov ID
- NCT04587921
- Acronym / sponsor ID
- MoxiCov / 5058/20/087
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 22 Jan 2021 (estimated)
- Study completion
- 22 Jun 2021 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of MoxiCov is to monitor the oximetry of patients admitted to the Covid nursery to provide a more detailed assistance expecting to reduce the amount of hypoxia in these patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients monitored with oximeter | Experimental | Device: Digital oximeter monitoringThe first 45 patients will be monitored but the results will not be displayed. The second half of the patients the oximeter will have their monitoring data available online in the ward. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 18 years old
- COVID 19 positive or suspected COVID19
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital oximeter monitoringDigital oximeter and cardiac frequency monitoring. | Device | Patients monitored with oximeter |
Primary outcome
Feasibility of the system: Determination of the number of valid versus not valid or missed measurements
Time frame: 6 months
Determination of the number of valid versus not valid or missed measurements of each participant.
Hypoxic burden
Time frame: 6 months
Time spent with SpO2< 93%, 90% and 85%
Hypoxic alarm
Time frame: 6 months
Number of times the oximeter record 3 consecutive measurements of SpO2<90%
Satisfaction of the nursing, medical team and patients with the implemented system
Time frame: 6 months
Measurement of NET PROMOTING SCORE (NPS). This score will show the satisfaction of the healthcare team with the device. This score have a minimum of 0 points and maximum of 32 points.
5 secondary outcomes
Time of SpO2<90%, SpO2<85% and SpO2<80%
Time frame: 6 months
Number of false alarms caused by malfunctions or bad oximeter positioning
Time frame: 6 months
Total hospital stay
Time frame: 6 months
Time of supplementary oxygen use
Time frame: 6 months
Mortality of participants
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital oximeter monitoring in people with Oximetry and Covid19, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diego Prieto, Msc (55 11 994385300, diego.campos.prieto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the system: Determination of the number of valid versus not valid or missed measurements (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.